The trial aimed to investigate the efficacy of obinutuzumab (G) plus CHOP versus rituximab (R) plus CHOP in patients with treatment naïve, advanced stage, CD20+, Diffuse Large B-Cell Lymphoma (DLBCL). Overall, 1,418 patients were enrolled from 207 centers across 29 counties and were randomized at a ratio of 1:1 to either G-CHOP (n=706) or R-CHOP (n=712). The primary outcome measure of the GOYA trial was investigator-assessed PFS.

Key Highlights:

Patients and treatment:

G: 1,000mg IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycles 2–8

A higher proportion of pts discontinued ≥1 components of study treatment due to an AE in the G-CHOP arm (n=84, 11.9%) versus the R-CHOP arm (n=60, 8.5%)

Fatal AEs: G-CHOP = 5.8% (41/704 pts); R-CHOP = 4.3% (30/703 pts)

Overall, CHOP combined with G or R achieved similar efficacy for PFS, as well as other secondary time-to-event end points. The authors also stated that “no new safety signals were identified”; however, infections, neutropenia, IRRs, cardiac events, thrombocytopenia, and hemorrhagic events of any grade, in addition to grade 3–5 AEs and SAEs, were more common with G-CHOP compared to R-CHOP.